HypertensionPhase 4CANTABILENCT01682564
To Evaluate the Efficacy and Safety on Blood Pressure In Patients With Hypertension Diagnosed Congestive Heart Failure
A Phase 4 study testing Candemore tablet and Atacand tablet in people with Hypertension and Congestive Heart Failure, run by Chong Kun Dang Pharmaceutical at 14 sites in South Korea.
Trial summary
To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension, Congestive Heart Failure
- What is being tested?
- Candemore tablet and Atacand tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing and able to provide written informed consent
- age 20 years or older
- patient with congestive heart failure, taking treatment medicine and NYHA grade II~III
- patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit
Who cannot join
- Known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease)
- blood creatinine level ≥ 2.5mg/dl
- blood potassium level > 5.5mEq/L
- blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic dysfunction, cholestasis
- pregnant or breast-feeding
- premenopausal women not using adequate contraception
Show all 11Show fewer
- patient has history about hypersensitivity or taboo of investigational product
- patient with lactose intolerance or Lapp lactase deficiency or glucode-galactose malabsorption
- administration of other study drugs within 1 month prior to screening
- history of ischemic heart disease(ex. angina pectoris, myocardial infarction) within the last 3 months
- in investigator's judgement
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Inje university pusan hospital
Busan, Busanjin-gu Gaegum-dong, 614-735
Daedong hospital
Busan, Dongnae-gu Myeongnyun-dong, 607-711
Inje university haeundae paik hospital
Busan, Haeundae-gu Heaundae-ro 875, 612-030
Maryknoll medical center
Busan, Jung-gu Daecheong-dong, 600-730
Kosin university gospel hospital
Busan, Seo-gu Amnam-dong, 602-702
Dong-A university medical center
Busan, Seo-gu Dongdaesin-dong, 602-715
Samsung changwon hospital
Changwon, Masanhoiwon-gu Hapseong-dong 50, 630-723
Daegu fatima hospital
Daegu, Dong-gu Sinam-dong, 701-724
Keimyung university dongsan medical center
Daegu, Jung-gu Dongsan-dong, 700-712
Kyungpook national university hospital
Daegu, Jung-gu Samdeok-dong, 700-721
Yeungnam university medical center
Daegu, Nam-gu Daemyeong-dong, 705-717
Daegu catholic univ. medical center
Daegu, Nam-gu Daemyung-dong, 705-718
Dongguk university gyeongju hospital
Gyeongju, Seokjang-dong, 780-350
Gyeongsang national university hospital
Jinju, Chiram-dong, 660-702
About this study
Official title: Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-center, Phase IV Study to Compare and Evaluate the Efficacy and Safety of Candemore Tab and Atacand Tab.
To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure
Read the detailed description
This is an open label, randomized, active drug comparative, Parallel group, Multi-center, phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured SBP ≥ 100mmHg and DBP > 60mmHg. Maximum dose is 16mg/day.
- Conditions
- Hypertension, Congestive Heart Failure
- Being tested
- Candemore tablet, Atacand tablet
- Keywords
- Candemore, Atacand, Candesartan cilexetil, Primary Hypertension, Congestive Hypertension
- Medical subject headings
- Hypertension, Heart Failure, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candemore tabletDrug
- Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
- dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
Atacand tabletDrug
- Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
- dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Candemore tablet | Experimental | Candemore tablet
* Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
* dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) Receives: Drug: Candemore tablet |
| Atacand tablet | Active comparator | Atacand tablet
* Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
* dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) Receives: Drug: Atacand tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sitting Systolic Blood Pressure
Measured: After 12 weeks of treatment
Secondary outcomes (4)
Mean Sitting Diastolic Blood Pressure
Measured: After 12 weeks of treatment
echocardiography
Left Ventricle Volume, Left Ventricle Ejection Fraction, E/E' ration, Peak TR velocity
Measured: After 12 weeks of treatment
Blood Creatinine and Potssium level
Measured: After 4 and 12 weeks of treatment
NYHA class
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KeeSik Kim, M.D Ph.D, Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682564
- Sponsor's protocol ID
- m106CHF11E
- Acronym
- CANTABILE
- Status last verified
- Sep 2015
- First submitted
- 4 Sep 2012
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Active Drug Comparative, Parallel Group, Multi-center, Phase IV Study to Compare and Evaluate the Efficacy and Safety of Candemore Tab and Atacand Tab.
- ClinicalTrials.gov ID
- NCT01682564
- Acronym / sponsor ID
- CANTABILE / m106CHF11E
- Conditions
- Hypertension, Congestive Heart Failure
- Keywords
- Candemore, Atacand, Candesartan cilexetil, Primary Hypertension, Congestive Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare and evaluate the efficacy and safety of Candemore tab. versus Atacand tab. on blood pressure in patients with hypertension diagnosed congestive heart failure
Detailed description
This is an open label, randomized, active drug comparative, Parallel group, Multi-center, phase IV study. Patients receive candemore tablet or atacand tablet. Initial dose is 4mg/day or 8mg/day. Every 2 weeks, patients take double dose if patients blood pressure is measured SBP ≥ 100mmHg and DBP > 60mmHg. Maximum dose is 16mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candemore tablet | Experimental | Drug: Candemore tabletCandemore tablet * Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg * dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) |
| Atacand tablet | Active comparator | Drug: Atacand tabletAtacand tablet * Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg * dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- willing and able to provide written informed consent
- age 20 years or older
- patient with congestive heart failure, taking treatment medicine and NYHA grade II~III
- patient with hypertension, taking treatment medicine or SBP ≥ 140mmHg or DBP ≥ 90mmHg at the screening visit
Key exclusion criteria (11 listed)
- Known or suspected secondary hypertension(ex. aortic coactation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma, cushing syndrome, polycystic renal disease)
- blood creatinine level ≥ 2.5mg/dl
- blood potassium level > 5.5mEq/L
- blood SGOT, SGPT level ≥ maximum normal range X3 or patient with sever hepatic dysfunction, cholestasis
- pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candemore tablet* Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg * dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) | Drug | Candemore tablet |
| Atacand tablet* Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg * dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day) | Drug | Atacand tablet |
Primary outcome
Mean sitting Systolic Blood Pressure
Time frame: After 12 weeks of treatment
4 secondary outcomes
Mean Sitting Diastolic Blood Pressure
Time frame: After 12 weeks of treatment
echocardiography
Time frame: After 12 weeks of treatment
Blood Creatinine and Potssium level
Time frame: After 4 and 12 weeks of treatment
NYHA class
Time frame: After 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KeeSik Kim, M.D Ph.D principal investigator
Daegu Catholic University Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candemore tablet and Atacand tablet in people with Hypertension and Congestive Heart Failure, run by Chong Kun Dang Pharmaceutical at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sitting Systolic Blood Pressure (time frame: After 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.